Controlled Trial to Evaluate the Safety and Efficacy of CYWC628 (Human Dermal Fibroblast Spheroids) for the Treatment of Refractory Diabetic Foot Ulcers Compared With Standard of Care

NCT07096934 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: CYWC628-CLIN-001
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, multicentre, randomized clinical trial evaluating the safety, tolerability, and efficacy of up to 12 weeks treatment with SoC + low- or high-dose CYWC628 in treating DFU, compared to SoC only.

Conditions

Diabetic Foot Ulcer (DFU)

Keywords

DFU; Diabetic ulcers; diabetic wounds; diabetic foot ulcers; chronic wounds; chronic ulcers; non-healing wounds

Outcome Measures

Primary Outcomes (3)

• Evaluate Adverse events, including severity grading using Common Terminology Criteria for Adverse Events (CTCAE v5.0), and relationship to treatment

  Evaluate the safety and tolerability of Standard of Care (SoC) + CYWC628 in patients with diabetic foot ulcer (DFU) as compared to SoC only. • Adverse events, including severity grading using Common Terminology Criteria for Adverse Events (CTCAE v5.0), and relationship to treatment.

  from enrollment to the end of the treatment at 12 weeks

• Evaluate proportion of participants with complete wound closure by 12 weeks after commencing study treatment or SoC

  Evaluate the efficacy of SoC + low dose and high dose CYWC628 in wound healing of DFU, compared with SoC only. Proportion of participants with complete wound closure by 12 weeks after commencing study treatment or SoC. Complete wound closure is defined as 100% re-epithelialization with no wound drainage, as determined by the Investigator, observed at 2 visits 2 weeks apart

  from enrollment to the end of the treatment at 12 weeks

• Evaluate percentage area reduction (PAR) of the DFU wound during the 12 week treatment period.

  Evaluate the safety and tolerability of Standard of Care (SoC) + CYWC628 in patients with diabetic foot ulcer (DFU) as compared to SoC only. Percentage area reduction (PAR) of the DFU wound during the 12 week treatment period.

  from enrollment to the end of the treatment at 12 weeks

Secondary Outcomes (4)

• Evaluate the treatment time to complete wound healing of DFU by SoC + CYWC628, compared to SoC only

  from enrollment to the end of the treatment at 12 weeks

• Complete wound closure and PAR in SoC patients offered treatment at the end of the 12 week primary outcome

  from enrollment to the end of the treatment at 12 weeks

• Evaluate DFU recurrence rate in patients with successful wound healing within 12 weeks of study treatment

  DFU at the same site within 6 months of original complete wound healing (last treatment). Time to recurrence of DFU within 6 months of complete wound healing (last treatment).

• Evaluate improvement in vascularization in patients administered SoC + CYWC628

  from enrollment to the end of the treatment at 12 weeks

Study Arms (3)

Standard of Care

ACTIVE COMPARATOR

Standard of care used for the treatment of diabetic foot ulcers once weekly for up to 12 weeks.

Other: Standard of Care (SOC)

SoC + Low dose CYWC628

EXPERIMENTAL

standard of care (SoC) + low dose CYWC628 applied once weekly to diabetic foot ulcer (DFU) for up to 12 weeks:

Biological: SoC + Low dose CYWC628

SoC + High dose CYWC628

EXPERIMENTAL

standard of care + high dose CYWC628 applied once weekly to diabetic foot ulcer (DFU) for up to 12 weeks:

Biological: SoC + High dose CYWC628

Interventions

Standard of Care (SOC) OTHER

The participant's DFU will be sharply debrided (as needed), dressed with SoC and offloaded.

Standard of Care

SoC + Low dose CYWC628 BIOLOGICAL

The participant's DFU will be sharply debrided (as needed), dressed with SoC and offloaded. Low dose CYWC628 applied once weekly to diabetic foot ulcer (DFU) for up to 12 weeks

SoC + Low dose CYWC628

SoC + High dose CYWC628 BIOLOGICAL

The participant's DFU will be sharply debrided (as needed), dressed with SoC and offloaded. High dose CYWC628 applied once weekly to diabetic foot ulcer (DFU) for up to 12 weeks

SoC + High dose CYWC628

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged 18 to 80 years inclusive at time of informed consent.
• Diagnosed/confirmed Type 1 or 2 diabetes mellitus.
• Presence of diabetic foot ulcer (DFU) at or below the level of the malleolus that is confined to one anatomical site and without exposure of bone and/or joint capsule.
• DFU Wagner Grade 1 or 2.
• DFU present for 12 to 52 weeks at time of Screening.
• DFU cross-sectional area of 50 to 1000 mm2 at Screening and Day 1.
• Resting ankle brachial index (ABI) ≥0.6 and ≤1.2, or toe pressure \>30 mmHg.
• HbA1c \<9%.
• Non-infected DFU (i.e., Infectious Diseases Society of America \[IDSA\] International Working Group on the Diabetic Foot \[IWGDF\] Classification 1/Uninfected) OR, at the discretion of the Investigator, DFU infection of IWGDF/IDSA Classification 2/Mild, at least within 2 weeks before and on Day 1.
• If there is evidence of infection during the Screening period (i.e., only IWGDF/IDSA Classification 2/ Moderate or 3/ Severe), the following will be performed:
• A skin pathogen test;
• Treatment with systemic or topical antibiotic or antifungal as deemed required by the Investigator. Systemic treatment must have ceased at least 5 days before Day 1. Ongoing topical antibiotic or antifungal treatment after randomization is permitted;
• Continue treatment of IWGDF/IDSA Classification 3/ Moderate infection as required until reduced to IWGDF/IDSA Classification 2/ Mild or 1/ no infection by at least 2 weeks before Day 1
• Sharp debridement of any further necrotic tissue, slough, or biofilm as needed.
• If participant of child bearing potential, must have a negative serum pregnancy test at screening and negative urine pregnancy test pre-first treatment on Day 1, and must agree to remain sexually abstinent, or use medically effective contraception (refer to Appendix 11.1), or have a partner who is sterile or same-sex, from Screening until at least 60 days after the last dose of study treatment. Males must not be planning to father children or donate sperm for the duration of the study and for at least 90 days after the last dose of study product.

You may not qualify if:

• The DFU had been previously treated, or is being treated, with growth factors, stem cells, or any equivalent preparation within 8 weeks before Screening.
• Enrolment in another interventional clinical foot ulcer healing trial within 4 weeks before Screening, or participation in any other interventional research study within 8 weeks before screening.
• Additional wound(s) within 3 cm of the study target wound.
• History of conditions that may impair wound healing in the opinion of the Investigator, for example, autoimmune disorders, renal failure patients on dialysis, or medications that impair the healing process. .
• DFU with exposure of bone and/or joint capsule.
• Active osteomyelitis, cellulitis, soft tissue infection, or Charcot's arthropathy present on the affected foot or limb containing the DFU, or DFU infection IWGDF/IDSA Classification 4/ Severe, or DFU infection IWGDF/IDSA Classification 3/ Moderate at Screening that cannot be reduced to Classification 2/ Mild or Classification 1/ No infection with treatment.
• Active healing and reduction of wound area ≥30% during the two-week period before Day 1.
• Known allergy to topical dressings, any of the study treatment components, and/or to gentamicin or other aminoglycosides.
• Pregnant or breastfeeding, or a male participant planning to father children or donate sperm during the study and for 90 days after last dose of study treatment.
• Current smoker of tobacco products and/or active user of nicotine replacement products including but not limited to nicotine gum, patches, or vaping.
• Current alcohol misuse as determined by the Investigator, and/or positive alcohol breath test at screening or pre-first treatment (no re-test permitted).
• Any other condition or situation that, in the opinion of the Investigator, would compromise the participant's ability to comply with study requirements.
• Known history of poor compliance with medical treatments.

Sponsors & Collaborators

• FibroBiologics: lead

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Hamid Khoja Chief Scientific Officer, Ph.D.

  FibroBiologics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamid Khoja Chief Scientific Officer, Ph.D.

CONTACT

281-671-5153; hamid.khoja@fibrobiologics.com

Pete O'Heeron Chief Executive Officer, MBA

CONTACT

281-671-5152; pete.oheeron@fibrobiologics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Approximately 120 participants will be randomized in parallel to one of the following treatment groups (40 participants per group): 1. SoC + Low dose CYWC628 2. SoC + High dose CYWC628 3. SoC only

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 31, 2025
• Study Start: September 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: At the end of the study and after the publication of the data.